FDA Label for Dianeal Low Calcium With Dextrose

Package/Label Principal Display Panel

Dianeal Representative Container Label THB9766 - 0941-0711.jpg - image 09

BaxterLogo
THB9766
2000 ml

Dianeal® PD-4 Low Calcium
with 1.5% Dextrose

EACH 100ml CONTAINS1.5 g DEXTROSE HYDROUS USP
538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE
18.3 mg CALCIUM CHLORIDE USP
5.08 mg MAGNESIUM CHLORIDE USP
pH5.2 (4.0 to 6.5)
mEq/LSODIUM 132 CALCIUM 2.5 MAGNESIUM 0.5 CHLORIDE 95
LACTATE 40 OSMOLARITY344 mOsmol/L(CALC)
STERILE NON PYROGENIC

POTASSIUM CHLORIDE TO BE ADDED ONLY UNDER THE DIRECTION OF A PHYSICIAN

READ PACKAGE INSERT FOR FULL INFORMATION
FOR INTRAPERITONEAL ADMINISTRATION ONLY
CAUTIONSSQUEEZE AND INSPECT INNER BAG WHICH
MAINTAINS PRODUCT STERILITY
DISCARD IF LEAKS ARE FOUND
DO NOT USE UNLESS SOLUTION IS CLEAR
DISCARD UNUSED PORTION

KEEP OUT OF REACH OF CHILDREN

AVOID EXCESSIVE HEAT SEE INSERT
INDICATED FOR CHRONIC RENAL FAILURE PATIENTS
BEING MAINTAINED ON PERITONEAL DIALYSIS

DIRECTIONTO BE USED AS DIRECTED BY THE PHYSICIAN

STORAGEBELOW 30°C
REG NO.2A 12/59
THRS1107
BH Symbol
MANUFACTURED BY:
BAXTER MANUFACTURING (THAILAND) CO. LTD.
RAYONG, THAILAND

PD-4
1.5%

Dianeal PD-4 Low Calcium with 1.5% Dextrose
THB9766
6 X 2000 mL

Each 100 ml contains
Dextrose Hydrous USP 1.5 g
Sodium Chloride USP 538 mg
Sodium Lactate 448 mg
Calcium Chloride USP 18.3 mg
Magnesium Chloride USP 5.08 mg
pH 5.2 (4.0-6.5)

Reg No. 2A 12/59

Manufacturing by
Baxter Manufacturing (Thailand) Co., Ltd.
Rayong, Thailand

Sterile, Nonpyrogenic Solution
Store below 30°C

Batch No. A20A007
MFD. 7 Jan 2020
EXP. 7 Jan 2022

Barcode
00002

(01)50085412528217(10)A20A007(17)220107

BaxterLogo
THB9776
2000 ml

Dianeal® PD-4 Low Calcium
with 2.5% Dextrose

EACH 100 ml CONTAINS2.5 g DEXTROSE HYDROUS USP
538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE 18.3 mg
CALCIUM CHLORIDE DIHYDRATE USP 5.08 mg MAGNESIUM
CHLORIDE HEXAHYDRATE USP pH5.2 (4.0 to 6.5)
mEq/LSODIUM 132 CALCIUM 2.5 MAGNESIUM 0.5 CHLORIDE 95
LACTATE 40 OSMOLARITY395 mOsmol/L(CALC)
STERILE NON PYROGENIC

POTASSIUM CHLORIDE TO BE ADDED ONLY UNDER THE DIRECTION OF A PHYSICIAN

READ PACKAGE INSERT FOR FULL INFORMATION
FOR INTRAPERITONEAL ADMINISTRATION ONLY
CAUTIONSSQUEEZE AND INSPECT INNER BAG WHICH
MAINTAINS PRODUCT STERILITY
DISCARD IF LEAKS ARE FOUND
DO NOT USE UNLESS SOLUTION IS CLEAR
DISCARD UNUSED PORTION KEEP OUT OF REACH OF CHILDREN

AVOID EXCESSIVE HEAT SEE INSERT
INDICATED FOR CHRONIC RENAL FAILURE PATIENTS
BEING MAINTAINED ON PERITONEAL DIALYSIS

DIRECTIONTO BE USED AS DIRECTED BY THE PHYSICIAN
STORAGEBELOW 30°C

REG NO.2A 95/59
THRS1109
BG Symbol

MANUFACTURED BY:
BAXTER MANUFACTURING (THAILAND) CO. LTD.
RAYONG, THAILAND

PD-4
2.5%

Dianeal PD-4 Low Calcium with 2.5% Dextrose
THB9776
6 X 2000 mL

Each 100 ml contains
Dextrose Hydrous USP 2.5 g
Sodium Chloride USP 538 mg
Sodium Lactate 448 mg
Calcium Chloride Dihydrate USP 18.3 mg
Magnesium Chloride Hexahydrate USP 5.08 mg

pH 5.2 (4.0-6.5)

Reg No. 2A 95/59

Manufacturing by
Baxter Manufacturing (Thailand) Co., Ltd.
Rayong, Thailand

Sterile, Nonpyrogenic Solution
Store below 30°C

Batch No. A20A023
MFD. 10 Jan 2020
EXP. 10 Jan 2022

Barcode
00001

(01)500854 12528224(10)A20A023(17)220110

BaxterLogo
THB9796IP
2000 ml

Peritoneal Dialysis Solution Low Calcium with
4.5% Dextrose-IP
Dianeal® PD-4 Low Calcium

EACH 100 ml CONTAINS4.25 g DEXTROSE HYDROUS 538 mg SODIUM CHLORIDE
448 mg SODIUM LACTATE 18.3 mg CALCIUM CHLORIDE DIHYDRATE 5.08 mg
MAGNESIUM CHLORIDE HEXAHYDRATE pH5.2 (4.5 to 6.5) mEq/L
SODIUM 132 CALCIUM 2.5 MAGNESIUM 0.5 CHLORIDE 95 LACTATE 40
OSMOLARITY483 mOsmol/L(CALC) STERILE NON PYROGENIC

POTASSIUM CHLORIDE TO BE ADDED ONLY UNDER THE DIRECTION OF A PHYSICIAN

FOR INTRAPERITONEAL ADMINISTRATION ONLY
CAUTIONSSQUEEZE AND INSPECT INNER BAG WHICH
MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND
DO NOT USE UNLESS SOLUTION IS CLEAR DISCARD UNUSED PORTION
KEEP OUT OF REACH OF CHILDREN AVOID EXCESSIVE HEAT
INDICATED FOR CHRONIC RENAL FAILURE PATIENTS
BEING MAINTAINED ON PERITONEAL DIALYSIS

INDICATION/ADMINISTRATION AND COMPLETE INFORMATION –REFER PACKAGE INSERT

STORAGEBELOW 30°C
THA REG NO.2A 93/59
THRS1131
AA Symbol

NAME AND ADDRESS OF MANUFACTURER:
BAXTER MANUFACTURING (THAILAND) CO., LTD.
7/398 MOO 6 MABYANGPORN, PLUAKDAENG, RAYONG, THAILAND 21140

Name and Address of Importer:
Baxter (India) Pvt. Ltd., No. 219-1A, 1B,225/4B, Block C, Ground Floor,
Kothari ware house, Opposite to Vegetarian Village, Madhavaram
Red Hills Road Puzhal village, Ambattur Taluk, Tiruvallur District,
Chennai – 600060 Tamil Nadu, India

Import License Number:IL/FF-000400 RC/FF-002173

Telephone no., email address (in case of consumer complaint, Safety Reporting or Queries):
Consumer Care No.: 0124-4603200
Consumer Care email ID: [email protected]

PEITONEAL DIALYSIS SOLUTION LOW
CALCIUM WITH 4.25% DEXTROSE-IP

PD-4
4.25%
DEXTROSE

(Dianeal® PD-4)
THB9796IP

Each 100 ml contains
Dextrose Hydrous 4.25 g
Sodium Chloride 538 mg
Sodium Lactate 448 mg
Calcium Chloride Dihydrate 18.3 mg
Magnesium Chloride Hexahydrate 5.08 mg

pH 5.2 (4.5-6.5)

Manufactured by
BAXTER MANUFACTURING (THAILAND) CO., LTD.,
7/398 MOO 6 MABYANGPORN, PLUAKDAENG,
RAYONG, THAILAND, 21140
NAME AND ADDRESS OF IMPORTER:
Baxter (India) Pvt. Ltd. No. 219-1A, 1B,225/4B, Block C,
Ground Floor, Kothari ware house, Opposite to Vegetarian Village,
Madhavaran Red Hills Road Puzhal village, Ambattur Taluk,
Tiruvallur District, Chennai – 600060 TAMILNADU, India

IMPORT LICENSE NUMBER: IL/FF-000400 RC/RF-002173

Sterile, Nonpyrogenic Solution
Store below 30°C

Batch No. A99A999
MFD. 99 Mar 9999
EXP. 99 Mar 9999

MRP Rs. 9999.99(incl. of all taxes)
Net Quality – 6 U X 2000 mL.

NAME, ADDRESS, TELEPHONE NO., EMAIL ADDRESS
(IN CASE OF CONSUMER COMPLAINT, SAFETY REPORTING OR QUERIES):
Baxter (India) Private Limited, 5 ^thFloor, Tower A, Building No. 9,
DLF Cyber City, DLF Phase III, Gurgaon – 122002/ Haryana, India
Consumer Care No.: 0124-4603200
Consumer Care email ID: [email protected]
Rev.01

Barcode
00001

(01)8859656197969(10)X21SXXX(17)231120